New Proposed Collection; Comment Request; Environmental Science Formative Research Methodology Studies for the National Children's Study, 38189-38190 [2011-16300]
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Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices
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[FR Doc. 2011–16234 Filed 6–28–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment
Request; Environmental Science
Formative Research Methodology
Studies for the National Children’s
Study
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval. This proposed
information collection was previously
published in the Federal Register on
April 27, 2011, pages 23603–23605, and
allowed 60 days for public comment.
One written comment was received. The
comment questioned the cost and utility
of the study specifically and of federally
funded biomedical research in general.
The purpose of this notice is to allow an
additional 30 days for public comment.
Proposed Collection
Title: Environmental Science
Formative Research Methodology
Studies for the National Children’s
Study (NCS).
Type of Information Collection
Request: Generic Clearance.
Need and Use of Information
Collection: The Children’s Health Act of
2000 (Pub. L. 106–310) states:
(a) PURPOSE.—It is the purpose of this
section to authorize the National Institute of
Child Health and Human Development* to
conduct a national longitudinal study of
environmental influences (including
physical, chemical, biological, and
psychosocial) on children’s health and
development.
(b) IN GENERAL.—The Director of the
National Institute of Child Health and
Human Development* shall establish a
consortium of representatives from
appropriate Federal agencies (including the
Centers for Disease Control and Prevention,
the Environmental Protection Agency) to—
(1) plan, develop, and implement a
prospective cohort study, from birth to
adulthood, to evaluate the effects of both
chronic and intermittent exposures on child
health and human development; and
(2) investigate basic mechanisms of
developmental disorders and environmental
factors, both risk and protective, that
influence health and developmental
processes.
(c) REQUIREMENT.—The study under
subsection (b) shall—
(1) incorporate behavioral, emotional,
educational, and contextual consequences to
enable a complete assessment of the physical,
chemical, biological, and psychosocial
environmental influences on children’s wellbeing;
(2) gather data on environmental
influences and outcomes on diverse
populations of children, which may include
the consideration of prenatal exposures; and
(3) consider health disparities among
children, which may include the
consideration of prenatal exposures.
To fulfill the requirements of the
Children’s Health Act, the results of
formative research will be used to
maximize the efficiency (measured by
scientific robustness, participant and
infrastructure burden, and cost) of
environmental sample collection
procedures and technology, storage
procedures, accompanying
questionnaires, and assays, and thereby
inform data collection methodologies
for the National Children’s Study (NCS)
Vanguard and Main Studies. With this
submission, the NCS seeks to obtain
OMB’s generic clearance to collect
environmental samples from homes and
child care settings, and conduct
accompanying short surveys related to
the physical and chemical environment.
The results from these formative
research projects will inform the
feasibility (scientific robustness),
acceptability (burden to participants
and study logistics) and cost of NCS
Vanguard and Main Study
environmental sample and information
collection in a manner that minimizes
public information collection burden
compared to burden anticipated if these
projects were incorporated directly into
either the NCS Vanguard or Main Study.
Frequency of Response: Annual [As
needed on an on-going and concurrent
basis].
Affected Public: Members of the
public, researchers, practitioners, and
other health professionals.
Type of Respondents: Women of
child-bearing age, fathers, public health
and environmental science professional
organizations and practitioners, and
schools and child care organizations.
These include both persons enrolled in
the NCS Vanguard Study and their peers
who are not participating in the NCS
Vanguard Study.
Annual reporting burden: See Table 1.
The annualized cost to respondents is
estimated at: $780,000 (based on $10 per
hour). There are no Capital Costs to
report. There are no Operating or
Maintenance Costs to report.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE
Type of respondent
Home Air ........................................
NCS participants ..................
VerDate Mar<15>2010
18:44 Jun 28, 2011
Jkt 223001
PO 00000
Frm 00082
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Data collection activity
Fmt 4703
4,000
Sfmt 4703
E:\FR\FM\29JNN1.SGM
Average burden
hours per
response
Estimated total
annual burden
hours requested
1
4,000
1
29JNN1
38190
Federal Register / Vol. 76, No. 125 / Wednesday, June 29, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN SUMMARY, ENVIRONMENTAL SCIENCE—Continued
Data collection activity
Home Water ..................................
Home Dust .....................................
School and Child Care Facility Air
School and Child Care Facility
Water.
School and Child Care Facility
Dust.
Small, focused survey and instrument design and administration.
Focus groups .................................
Cognitive interviews .......................
mstockstill on DSK4VPTVN1PROD with NOTICES
Total ........................................
Members of NCS target
population (not NCS participants).
NCS participants ..................
Members of NCS target
population (not NCS participants).
NCS participants ..................
Members of NCS target
population (not NCS participants).
NCS participants ..................
Members of NCS target
population (not NCS participants).
NCS participants ..................
18:44 Jun 28, 2011
Average burden
hours per
response
Estimated total
annual burden
hours requested
4,000
1
1
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
4,000
1
1
1
1
4,000
4,000
4,000
1
1
4,000
Members of NCS target
population (not NCS participants).
NCS participants ..................
4,000
1
1
4,000
4,000
1
1
4,000
Members of NCS target
population (not NCS participants).
NCS participants ..................
4,000
1
1
4,000
4,000
2
1
8,000
Members of NCS target
population (not NCS participants).
Health and Social Service
Providers.
Community Stakeholders ....
NCS participants ..................
Members of NCS target
population (not NCS participants).
Health and Social Service
Providers.
Community Stakeholders ....
NCS participants ..................
Members of NCS target
population (not NCS participants).
4,000
2
1
8,000
2,000
1
1
2,000
2,000
2,000
2,000
1
1
1
1
1
1
2,000
2,000
2,000
2,000
1
1
2,000
2,000
500
500
1
1
1
1
2
2
2,000
1,000
1,000
..............................................
69,000
............................
............................
78,000
Request for comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to minimize
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
VerDate Mar<15>2010
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of respondent
Jkt 223001
mechanical, or other technological
collection techniques or other forms of
information technology.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Sarah L.
Glavin, Deputy Director, Office of
Science Policy, Analysis and
Communication, National Institute of
Child Health and Human Development,
31 Center Drive, Room 2A18, Bethesda,
Maryland 20892, or call non-toll free
number (301) 496–1877 or E-mail your
request, including your address to
glavins@mail.nih.gov.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00083
Fmt 4703
Sfmt 4703
Comments due date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30 days of the date of
this publication.
DATES:
Dated: June 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy,
Analysis and Communications, National
Institute of Child Health and Human
Development.
[FR Doc. 2011–16300 Filed 6–28–11; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\29JNN1.SGM
29JNN1
]]>Agencies
[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Notices]
[Pages 38189-38190]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16300]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
New Proposed Collection; Comment Request; Environmental Science
Formative Research Methodology Studies for the National Children's
Study
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Institute of Child
Health and Human Development (NICHD), the National Institutes of Health
(NIH) will publish periodic summaries of proposed projects to be
submitted to the Office of Management and Budget (OMB) for review and
approval. This proposed information collection was previously published
in the Federal Register on April 27, 2011, pages 23603-23605, and
allowed 60 days for public comment. One written comment was received.
The comment questioned the cost and utility of the study specifically
and of federally funded biomedical research in general. The purpose of
this notice is to allow an additional 30 days for public comment.
Proposed Collection
Title: Environmental Science Formative Research Methodology Studies
for the National Children's Study (NCS).
Type of Information Collection Request: Generic Clearance.
Need and Use of Information Collection: The Children's Health Act
of 2000 (Pub. L. 106-310) states:
(a) PURPOSE.--It is the purpose of this section to authorize the
National Institute of Child Health and Human Development* to conduct
a national longitudinal study of environmental influences (including
physical, chemical, biological, and psychosocial) on children's
health and development.
(b) IN GENERAL.--The Director of the National Institute of Child
Health and Human Development* shall establish a consortium of
representatives from appropriate Federal agencies (including the
Centers for Disease Control and Prevention, the Environmental
Protection Agency) to--
(1) plan, develop, and implement a prospective cohort study,
from birth to adulthood, to evaluate the effects of both chronic and
intermittent exposures on child health and human development; and
(2) investigate basic mechanisms of developmental disorders and
environmental factors, both risk and protective, that influence
health and developmental processes.
(c) REQUIREMENT.--The study under subsection (b) shall--
(1) incorporate behavioral, emotional, educational, and
contextual consequences to enable a complete assessment of the
physical, chemical, biological, and psychosocial environmental
influences on children's well-being;
(2) gather data on environmental influences and outcomes on
diverse populations of children, which may include the consideration
of prenatal exposures; and
(3) consider health disparities among children, which may
include the consideration of prenatal exposures.
To fulfill the requirements of the Children's Health Act, the
results of formative research will be used to maximize the efficiency
(measured by scientific robustness, participant and infrastructure
burden, and cost) of environmental sample collection procedures and
technology, storage procedures, accompanying questionnaires, and
assays, and thereby inform data collection methodologies for the
National Children's Study (NCS) Vanguard and Main Studies. With this
submission, the NCS seeks to obtain OMB's generic clearance to collect
environmental samples from homes and child care settings, and conduct
accompanying short surveys related to the physical and chemical
environment.
The results from these formative research projects will inform the
feasibility (scientific robustness), acceptability (burden to
participants and study logistics) and cost of NCS Vanguard and Main
Study environmental sample and information collection in a manner that
minimizes public information collection burden compared to burden
anticipated if these projects were incorporated directly into either
the NCS Vanguard or Main Study.
Frequency of Response: Annual [As needed on an on-going and
concurrent basis].
Affected Public: Members of the public, researchers, practitioners,
and other health professionals.
Type of Respondents: Women of child-bearing age, fathers, public
health and environmental science professional organizations and
practitioners, and schools and child care organizations. These include
both persons enrolled in the NCS Vanguard Study and their peers who are
not participating in the NCS Vanguard Study.
Annual reporting burden: See Table 1. The annualized cost to
respondents is estimated at: $780,000 (based on $10 per hour). There
are no Capital Costs to report. There are no Operating or Maintenance
Costs to report.
Table 1--Estimated Annual Reporting Burden Summary, Environmental Science
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Estimated total
Data collection activity Type of respondent number of responses per hours per annual burden
respondents respondent response hours requested
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home Air...................................... NCS participants................ 4,000 1 1 4,000
[[Page 38190]]
Members of NCS target population 4,000 1 1 4,000
(not NCS participants).
Home Water.................................... NCS participants................ 4,000 1 1 4,000
Members of NCS target population 4,000 1 1 4,000
(not NCS participants).
Home Dust..................................... NCS participants................ 4,000 1 1 4,000
Members of NCS target population 4,000 1 1 4,000
(not NCS participants).
School and Child Care Facility Air............ NCS participants................ 4,000 1 1 4,000
Members of NCS target population 4,000 1 1 4,000
(not NCS participants).
School and Child Care Facility Water.......... NCS participants................ 4,000 1 1 4,000
Members of NCS target population 4,000 1 1 4,000
(not NCS participants).
School and Child Care Facility Dust........... NCS participants................ 4,000 1 1 4,000
Members of NCS target population 4,000 1 1 4,000
(not NCS participants).
Small, focused survey and instrument design NCS participants................ 4,000 2 1 8,000
and administration.
Members of NCS target population 4,000 2 1 8,000
(not NCS participants).
Health and Social Service 2,000 1 1 2,000
Providers.
Community Stakeholders.......... 2,000 1 1 2,000
Focus groups.................................. NCS participants................ 2,000 1 1 2,000
Members of NCS target population 2,000 1 1 2,000
(not NCS participants).
Health and Social Service 2,000 1 1 2,000
Providers.
Community Stakeholders.......... 2,000 1 1 2,000
Cognitive interviews.......................... NCS participants................ 500 1 2 1,000
Members of NCS target population 500 1 2 1,000
(not NCS participants).
-----------------------------------------------------------------------
Total..................................... ................................ 69,000 ................ ................ 78,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Request for comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to minimize the burden of the collection
of information on those who are to respond, including the use of
appropriate automated, electronic, mechanical, or other technological
collection techniques or other forms of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Dr. Sarah L. Glavin, Deputy Director, Office of
Science Policy, Analysis and Communication, National Institute of Child
Health and Human Development, 31 Center Drive, Room 2A18, Bethesda,
Maryland 20892, or call non-toll free number (301) 496-1877 or E-mail
your request, including your address to glavins@mail.nih.gov.
DATES: Comments due date: Comments regarding this information
collection are best assured of having their full effect if received
within 30 days of the date of this publication.
Dated: June 21, 2011.
Sarah L. Glavin,
Deputy Director, Office of Science Policy, Analysis and Communications,
National Institute of Child Health and Human Development.
[FR Doc. 2011-16300 Filed 6-28-11; 8:45 am]
BILLING CODE 4140-01-P
